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Recruiting NCT01885299

RSSearch Patient Registry-Long Term Study of Use of SRS/SBRT

— Observational Neoplasms Arteriovenous Malformation of Central Nervous System Trigeminal Neuralgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SRS/SBRT.
Who it may be relevant to
Registry conditions: Neoplasms, Arteriovenous Malformation of Central Nervous System, Trigeminal Neuralgia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multi-Institution Registry of SRS/SBRT Procedures

Overview

The RSSearch® Registry is an international multi-year database designed to track SRS/SBRT (Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy) utilization, treatment practices and outcomes to help determine, over time, the most effective use of these systems in management of patients with life threatening tumors and other diseases. (This study was formally called ReCKord and included the CyberKnife only; The ReCKord study continues as a CyberKnife subset of RSSearch.)

Detailed description

The Registry is designed to help SRS/SBRT (Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy) users to understand utilization of and key treatment outcomes for these treatment approaches. Some of the objectives include:

Allow participants to record information about usage of SRS/SBRT in everyday practice, including patient characteristics and disease information, treatment plans and outcomes Provide participants with ready access to data for publication of their own experience and as a tool for establishing collaborations with other participating sites Facilitate quality improvement efforts for individual treatment providers Understand the effectiveness of different treatment plans for different types of lesions, diseases and treatments

The Registry tracks select outcomes for each condition treated by SRS/SBRT (for example, PSA for prostate cancer); the Registry also provides individual participants the ability to add additional outcomes for each and any condition of specific interest to their institutions.

The Registry is hosted by Vision Tree, Inc who is an independent vendor of electronic registries; they are responsible for HIPAA compliance, including all security mechanisms.

Patients will be enrolled prospectively. Some retrospective patient data is likely to be included in order to capture both short and longer term outcomes data.

Interventions

  • Radiation SRS/SBRT
    Intervention varies by condition being treated.

Primary outcome measures

  • Overall survival [Time frame: Up to 5 years]
Secondary outcome measures (1)
  • Local and distant recurrence [Time frame: One to Five years]

Eligibility criteria

Inclusion criteria

  • Diagnosis of benign or malignant tumors or other conditions deemed treatable by stereotactic radiosurgery or stereotactic body radiotherapy
  • Willingness to sign an Informed Consent Document or verbally agree to participation

Exclusion criteria

  • There are no specific exclusion criteria, but patients who are unwilling to sign the ICD or who decline participation will not be included

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 13 centers
  • Penrose Cancer Center — Colorado Springs
  • Sylvester Comprehensive Cancer Center, University of Miami — Miami
  • Southeast Georgia Health System — Brunswick
  • Henry Ford Health System — Detroit
  • AtlantiCare Regional Medical Center and AtlantiCare Cancer Care Institute — Egg Harbor
  • Riverview Medical Center — Red Bank
  • NJ Cyberknife at Community Medical Center — Toms River
  • Montefiore Medical Center — The Bronx
  • … and 5 more centers

Publications

  • Tipton KN, Sullivan N, Bruening W, Inamdar R, Launders J, Uhl S, Schoelles KM. Stereotactic Body Radiation Therapy [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 May. Report No.: 10(11)-EHC058-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK55723/ PMID 21735562
  • Dieterich S, Gibbs IC. The CyberKnife in clinical use: current roles, future expectations. Front Radiat Ther Oncol. 2011;43:181-194. doi: 10.1159/000322423. Epub 2011 May 20. PMID 21625154
  • Wowra B, Muacevic A, Tonn JC. CyberKnife radiosurgery for brain metastases. Prog Neurol Surg. 2012;25:201-9. doi: 10.1159/000331193. Epub 2012 Jan 6. PMID 22236681
  • Sarwate D, Sarkar S, Krimsky WS, Burgan CM, Patel K, Evans R, Harley DP. Optimization of mediastinal staging in potential candidates for stereotactic radiosurgery of the chest. J Thorac Cardiovasc Surg. 2012 Jul;144(1):81-6. doi: 10.1016/j.jtcvs.2012.03.004. Epub 2012 Apr 11. PMID 22498085
  • Sohn S, Chung CK. The role of stereotactic radiosurgery in metastasis to the spine. J Korean Neurosurg Soc. 2012 Jan;51(1):1-7. doi: 10.3340/jkns.2012.51.1.1. Epub 2012 Jan 31. PMID 22396835
  • Davis JN, Medbery C, Sharma S, Pablo J, Kimsey F, Perry D, Muacevic A, Mahadevan A. Stereotactic body radiotherapy for centrally located early-stage non-small cell lung cancer or lung metastases from the RSSearch((R)) patient registry. Radiat Oncol. 2015 May 15;10:113. doi: 10.1186/s13014-015-0417-5. PMID 25975848
  • Davis JN, Medbery C 3rd, Sharma S, Perry D, Pablo J, D'Ambrosio DJ, McKellar H, Kimsey FC, Chomiak PN, Mahadevan A. Stereotactic body radiotherapy for early-stage non-small cell lung cancer: clinical outcomes from a National Patient Registry. J Radiat Oncol. 2015;4(1):55-63. doi: 10.1007/s13566-014-0177-0. Epub 2015 Jan 31. PMID 25774243
  • Davis JN, Medbery C 3rd, Sharma S, Danish A, Mahadevan A. The RSSearch Registry: patterns of care and outcomes research on patients treated with stereotactic radiosurgery and stereotactic body radiotherapy. Radiat Oncol. 2013 Nov 25;8:275. doi: 10.1186/1748-717X-8-275. PMID 24274599

Identifiers

NCT: NCT01885299 · RSSearch Patient Registry

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗